NCT00889733终止1 期
A Phase I/II Trial of Intraperitoneal (IP) Cisplatin Combined With IV Paclitaxel in Patients With Epithelial Ovarian Cancer Optimally Debulked at Their Initial Surgery Performed Following Neoadjuvant Intravenous Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Safety and Dose Tolerance
研究概览
简要总结
The purpose of this study is to determine whether intraperitoneal (IP) Cisplatin combined with intravenous (IV) Paclitaxel is well tolerated in women with epithelial ovarian cancer who have had neoadjuvant chemotherapy followed by initial debulking surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven epithelial ovarian cancer
- •Previously received no more than 4 cycles of neoadjuvant platinum based chemotherapy, followed by debulking surgery
- •ECOG PFS <_ 2
- •Adequate haematological (absolute neutrophil count >_ 1,500/mm3; platelets >_ 100,000/mm3; hemoglobin >_ 100g/L); renal (<_ upper limit of normal) and hepatic function
- •Age >_ 18 years
- •Written informed consent and the ability of the patient to co-operate with treatment and follow up
排除标准
- •Contraindication to platinum/Paclitaxel chemotherapy: prior anaphylaxis to Carboplatin/Paclitaxel, unresolved or excessive toxicity from neoadjuvant chemotherapy. Patients must not have suffered significant bone marrow suppression during prior treatment. The significance of previous treatment delay and/or dose modification is to be determined by the Principle Investigator on a patient-by-patient basis.
- •Serious concomitant medical condition, which in the investigators opinion would not make the patient a good candidate for the clinical trial.
- •Patients with a past or concomitant malignancy other than skin cancer (excluding melanoma)
- •Patients known to be serologically positive for Hepatitis B, C or HIV
- •History of congestive heart failure or unstable angina or those who had a myocardial infarction within the past 6 months. Patients who were not expected to tolerate the hemodynamic effects of the fluid administered as part of the IP protocol.
- •Patients who have not received chemotherapy prior to surgery
- •Greater than 6 weeks from time of surgery to commencement of IP chemotherapy
- •Residual disease greater than 1 cm at time of surgery. Patients whom in the surgeon's opinion are candidates for such surgery may be consented preoperatively to allow intraoperative IP catheter insertion. If however the surgeon is not able to reduce the bulk of disease to less than or equal to 1 cm, patients will be removed from the study and an IP catheter SHOULD NOT be placed.
研究组 & 干预措施
IP Cisplatin
Experimental
Patients with epithelial ovarian cancer who have undergone optimal debulking surgery receive IP Cisplatin with IV Paclitaxel.
干预措施: Intraperitoneal (IP) Cisplatin (Drug)
结局指标
主要结局
Safety and Dose Tolerance
时间窗: Day 1 of each cycle and assessed every 3 months in follow-up (if applicable)
次要结局
- Time to progression(Day 1 of cycle 1 & 2 and every 3 months in follow-up until progression noted)
研究者
研究点 (1)
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